| Class 2 Device Recall LEEP PRECISION Integrated System 120V | |
Date Initiated by Firm | September 29, 2021 |
Create Date | November 18, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0257-2022 |
Recall Event ID |
88648 |
510(K)Number | K963348 |
Product Classification |
Electrocautery, gynecologic (and accessories) - Product Code HGI
|
Product | LEEP PRECISION Integrated System, 120V
CooperSurgical part number: LP-10-120 |
Code Information |
Serial Numbers: Lot/Serial Number 0115001 0115001 0115001 0115002 0115003 0115004 0115005 0115005 0115006 0115007 0115007 0115008 0115009 0115010 0115011 0115012 0115012 0115013 0115014 0115015 0115015 0115016 0115017 0115018 0115019 0115020 0115021 0115022 0115023 0115024 0115025 0115026 0115027 0115028 0115029 0115030 0115031 0115032 0115033 0115034 0115035 0115036 0115037 0115038 0115039 0115040 0215001 0215003 0215004 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215019 0215020 0215021 1114001 1114002 1114003 1114004 1114005 1114006 1114007 1114008 1114009 1114010 1114011 1114012 1114013 1114013 1114014 1114015 1114016 1114017 1114018 1114019 1114020 1114021 1114022 1114023 1114024 1114025 1114026 1114027 1114028 1214001 1214002 1214003 1214004 1214005 1214005 1214006 1214007 2015060001 2015060002 2015060003 2015060004 2015060004 2015060005 2015060006 2015060007 2015060008 2015060009 2015060010 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Recalling Firm/ Manufacturer |
CooperSurgical, Inc. 95 Corporate Dr Trumbull CT 06611-1350
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For Additional Information Contact | Customer Service 203-601-9818 |
Manufacturer Reason for Recall | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. |
FDA Determined Cause 2 | Component design/selection |
Action | CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take:
This Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you.
Please feel free to reach us at 203-601-5200 ext. 3300.
Please complete this form and return it via email: recall@coopersurgical.com or fax to 203.601.9870
ATTN: Product Surveillance. CooperSurgical will arrange for a product repair after this form has been received.
Firm issued additional letter for the product LP-10-220 as it was not included in the initial recall letter. The letter dated 10/18/21 distributed to international accounts only. |
Quantity in Commerce | 1587 Units |
Distribution | US Nationwide Distribution
Foreign:
ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HGI
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